Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants
Recruiting
Phase 1
Phase 2
Interventional Study
MASH
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- OPKO Health, Inc. · Industry
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About This Trial
Two-part Phase 1/2 study of OPK-88006, including an open-label SAD phase in healthy participants and a double-blind, randomized, placebo-controlled MAD phase in participants with presumed MASH, to evaluate safety, PK, and MASH related pharmacodynamic changes compared to placebo.
Trial Locations
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Eligibility Criteria
Part A (SAD)
Inclusion Criteria:
* Adults aged 18-65 years.
* BMI ≥27 and ≤35 kg/m².
* Good general health per investigator assessment.
* Willing to comply with contraception, trial procedures, and stable diet/exercise.
Exclusion Criteria:
* Significant uncontrolled medical or psychiatric histor…
Contacts